Model Number 302-20 |
Device Problems
Corroded (1131); Fracture (1260); Mechanical Problem (1384)
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Patient Problem
Nerve Damage (1979)
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Event Date 12/22/2016 |
Event Type
malfunction
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Event Description
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It was reported that the patient was referred for a lead and generator replacement due to high impedance being observed.During the replacement surgery it was noted that the patient's vagus nerve appeared to be damaged.The surgeon reported that the nerve appeared atrophic and discolored immediately around and under the positive and negative electrodes.The surgeon could not determine the cause of the nerve's appearance but noted that the electrodes seemed to be more degenerated than usual.The explanted lead and generator were discarded following the surgery.Therefore product analysis cannot be completed.No additional relevant information has been received to date.
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Manufacturer Narrative
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Corrected data: describe event or problem; "it was reported that during the replacement surgery the lead's electrode appeared to be corroded.After the lead and generator were replaced the new system was programmed on and the patient began coughing.The physician believed that the coughing was caused by the nerve damage sustained from the explanted lead and generator." this information was inadvertently left off on mfg.Report #0.Corrected data: (b)(4).This information was inadvertently left off on mfg.Report #0.
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Event Description
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It was reported that during the replacement surgery the lead's electrode appeared to be corroded.After the lead and generator were replaced the new system was programmed on and the patient began coughing.The physician believed that the coughing was caused by the nerve damage sustained from the explanted lead and generator.The explanted lead and generator were received and are currently pending analysis.
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Event Description
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Analysis of the generator and lead were completed.As a part of testing the generator's output signal was monitored for a 24 hour period while it was placed in a simulated body temperature environment.During this period there were no observed variations in the output current of the generator.Analysis confirmed that the generator performed to functional specifications.It was noted that the lead was received as one portion which did not contain the electrodes or tie downs.Setscrew marks were observed on the lead's connector pin which indicated that at one time there had been proper mechanical contact between the generator and lead.Abrasions were observed in the outer tubing and it appeared that the cause of these abrasions were related to wear.A continuity check was performed on the returned lead portion and no discontinuities were identified.The analysis was unable to confirm the presence of a fracture in the portion of the lead that had been received.
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Search Alerts/Recalls
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